Notes on the First Public FDA Meeting on CBD

Last Friday, May 31, the Food and Drug Administration (“FDA”) held its first public meeting during which stakeholders shared their perspective on how to regulate cannabidiol (“CBD”)-infused products. The objective of the meeting was to gather scientific data and information about the safety, manufacturing, product quality, marketing, labeling and sale of these products.

As we have explained in previous blog posts (here and here), the FDA currently treats the sale and marketing of CBD-infused food and dietary supplement in interstate commerce as unlawful because CBD was approved as a drug by the agency before it was marketed as a food or a dietary supplement. Accordingly, CBD cannot be marketed simultaneously as a food/dietary supplement and a drug.u

Although nothing groundbreaking  came out of the nearly 10-hour long meeting, we thought it would be interesting to highlights some of the major topics discussed during this meeting.

PROPONENTS AND OPPONENTS
Several hemp and cannabis organizations, including the U.S. Hemp Roundtable, argued that the FDA should allow the sale of hemp-derived CBD-infused products given the congressional intent behind the 2018 Farm Bill, which legalized hemp and its derivatives. In addition, the U.S. Hemp Roundtable mentioned ongoing efforts with lawmakers to draft legislation that would regulate hemp-derived CBD-infused products in the event the FDA concludes that it cannot design a regulatory framework on its own. This scenario seems plausible given Former FDA Commissioner Scott Gottlieb’s statement that Congress may hold the key to legalizing CBD-infused products by issuing additional legislation that expressly allow the use of Hemp-CBD in foods. Indeed, while the intend of Congress was undeniably to legalize the production of crop and its derivatives, Congress did not define the term” production,” thus leaving open for interpretation whether the sale of hemp-derived CBD-infused products is legal.

Supporters of hemp-derived CBD-infused products also suggested that these products be regulated under the existing dietary supplement framework, where products are intended for non-medicinal purposes.

While some speakers expressed concerns regarding the sale of cannabis-infused products; their concerns were primarily directed at marijuana-infused products.

REGULATORS
State regulators discussed the need for FDA guidelines in regulating these products.

Specifically, Brenda Morris, Florida Department of Agriculture and Consumer Services, discussed the “patchwork of laws” surrounding CBD products that has created an environment in which “anything is allowed.”

Pam Miles, a representative of the Virginia Department of Agriculture, raised the lack of scientific evidence regarding CBD products and urged the FDA to take the lead on this issue:

Currently, states are struggling with the lack of sound scientific research available in CBD and long-term health impacts, including those to children’ and that her department “is hopeful that FDA will begin to supply significant leadership as it related to CBD, including research related to its health impacts.”

HEALTH AND CONSUMER ADVOCATES
Health and consumer advocates also weighed in on the issue and expressed concerns regarding the lack of scientific research needed to substantiate claims about the therapeutic value of CBD in treating various illnesses, including Alzeimer’s, dementia, and epilepsy – despite the FDA approval of Epidiolex.

Others stressed the need to adopt terminology, manufacturing and standards for these products in order to protect the consumer and avoid a public health crisis.

While speakers had various opinions regarding how stringent those rules and regulations should be, all agreed that a regulatory framework was needed immediately. The FDA has previously declared that creating a framework for allowing CBD into the food supply would take sometime; however, the agency is hoping to share information and/or finding with the public, as Gottlieb explained in his April 2 statement, as early as this summer (but no sooner than July 2, which is the last day to submit public comments).

Until then, the CBD industry will need to continue navigating through these murky waters.

Notes on the First Public FDA Meeting on CBD posted first on http://ronenkurzfeld.blogspot.com